QUININE SULFATE Drug Patent Profile
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When do Quinine Sulfate patents expire, and what generic alternatives are available?
Quinine Sulfate is a drug marketed by Amneal Pharms, Aurobindo Pharma Usa, Lupin Ltd, Novast Labs, and Teva Pharms. and is included in five NDAs.
The generic ingredient in QUININE SULFATE is quinine sulfate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the quinine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Quinine Sulfate
A generic version of QUININE SULFATE was approved as quinine sulfate by TEVA PHARMS on September 28th, 2012.
Summary for QUININE SULFATE
US Patents: | 0 |
Applicants: | 5 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 205 |
Clinical Trials: | 17 |
Patent Applications: | 3,132 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for QUININE SULFATE |
What excipients (inactive ingredients) are in QUININE SULFATE? | QUININE SULFATE excipients list |
DailyMed Link: | QUININE SULFATE at DailyMed |
Recent Clinical Trials for QUININE SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hiroshi Mitsumoto | Phase 1/Phase 2 |
Prodia Diacro Laboratories P.T. | N/A |
National Research and Innovation Agency of Indonesia | N/A |
Pharmacology for QUININE SULFATE
Drug Class | Antimalarial |
Medical Subject Heading (MeSH) Categories for QUININE SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for QUININE SULFATE
US Patents and Regulatory Information for QUININE SULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal Pharms | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 203729-001 | Jul 15, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novast Labs | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 204372-001 | Jul 22, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Aurobindo Pharma Usa | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 202581-001 | Dec 14, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lupin Ltd | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 203112-001 | Apr 24, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |